Chidamide is included in national health care, and the innovative medicine benefits vast number of patients

August 03,2017

Chidamide is included in new national health insurance catalog

It is Type B of medical insurance, which is suitable for relapsed or refractory peripheral T-cell lymphoma (PTCL)

On July 13, 2017, the Ministry of Human Resources and Social Security issued a notice on the inclusion of 36 drugs in category B of the national basic medical insurance, industrial injury insurance and maternity insurance drug list. Chidamide (trade name: Epidaza?), a new anti-tumor drug originally developed by China, was successfully included in the newly selected national medical insurance list.

Chidamide is a new generation of epigenetic regulatory drugs developed by Shenzhen CHIPSCREEN BIOSCIENCES. It is an anti-tumor class 1.1 chemical new drug for oral subtype selective histone deacetylase inhibitors and suitable for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one systemic chemotherapy in the past. It is the first PTCL drug approved for treatment of relapses or refractory cases in China and the first chemical new drug developed by our country independently for simultaneous global development. Meanwhile, it is also one of the major national new drug discovery achievements and the first " orphan drug" independently developed in China for the treatment of rare diseases.

Chidamide's inclusion in the new national health care catalog is an effective measure by the state to solve the plight of more economically poor patients with peripheral T-cell lymphoma, which fully reflects the party's and the state's focus on patients' needs and is also an acknowledgement of the benefits of Chidamide's clinical treatment as an independent innovative drug.


The medical insurance negotiation mechanism allows the common people to take effective and good medicines.

Medical insurance has always been an important role in deepening the reform of the medical and health system. It not only concerns people's livelihood, but also affects the development of the industry. After eight years, the 2017 revision of the medical insurance catalog has become one of the most noticeable policies in the medical industry this year. Among them, the first-time opening of the drug negotiation access mechanism is undoubtedly the greatest progress of the medical reform system.

In February 2015, the general office of the state Council issued the guiding opinions on improving the centralized purchasing of drugs in public hospitals as the general office of the state Council, clearly stating that "drugs with definite clinical efficacy, significant innovative value, but expensive prices are introduced into the drug price negotiation mechanism." In October, the guidelines on improving centralized drug purchase in public hospitals ( from the general office of the state Council [ 2015 ] No. 7 ) were issued, proposing new ideas for classified purchase, requiring the establishment of an open, transparent and multi-party drug price negotiation mechanism for some patented drugs and exclusively manufactured drugs. The Ministry of Human Resources and Social Security began organizing the first batch of national drug price negotiation pilot work and formally launched the national drug price negotiation pilot in late November. According to China's major drug demand for public health and disease prevention and control, guided by problems and goals, responding to social concerns, organizing experts to fully demonstrate, and selecting patented medicines with high price, and obvious benefits to patients for negotiation. The national drug price negotiation is of great significance. According to the prevailing international practice, a unified negotiation method is adopted to negotiate with drug companies with a large market share of a country in order to obtain a more reasonable price for patients. The medical insurance drug list hopes to establish a price negotiation mechanism through this negotiation to include reimbursement of some major diseases, special diseases and orphan drugs into the scope of medical insurance coverage, which not only reflects social care for patients with major diseases, special diseases and orphan diseases, but also establishes a reasonable reimbursement and allocation mechanism.

Chidamide has a definite curative effect and has been listed in the national health insurance for only two years.

After 13 years of research and development, Chidamide(Epidaza?) was approved by CFDA to be listed in December 2014. It is suitable for the treatment of patients with relapsed and refractory peripheral T-cell lymphoma, which is the first subtype of selective histone deacetylase (HDAC) oral inhibitor in the world. Through the licensing of overseas patents in Chidamide in 2006, it became the first original new drug in China to authorize patents in developed countries such as the United States. At present, it has entered phase II clinical trials and registered clinical trials in the United States and Japan, realizing the global synchronous development of original new drugs in China. in 2016, it was named as the most clinically valuable innovative drug.

Peripheral T-cell Lymphoma (PTCL) is a group of highly heterogeneous lymphoproliferative disorders with a morbidity of 1 / 100,000. Its response rate to conventional chemotherapy is low and it is easy to relapse. The overall 5-year survival rate of patients is only 25-30%, which is lack of effective therapeutic drugs. The research and development of Chidamide has been listed on the market, which has solved this clinical demand very well. Analysis of 703 clinical active monitoring programs in Chidamide reported at the CSCO annual meeting in September 2016 shows that more than 60% of patients can benefit from the treatment of oral Chidamide. Nearly 40 experts from the five major blood lymphoma professional associations in China participated in the preparation of the " Chinese experts’ consensus on the treatment of peripheral T-cell lymphoma in Chidamide (2016 edition)". Several domestic clinical experts have advanced in the stage of several clinical studies on the rational application of Chidamide to NKT-cell lymphoma and peripheral T-cell lymphoma, which have reached the leading level in the treatment of related diseases and been invited to participate in several thematic reports and seminars of international conferences (including the American T-cell lymphoma conference in 2015, 2016, 2017, the European T-cell lymphoma conference in 2016, the Lugano conference in 2017, etc. ).

Compared with other new international PTCL medicines, Chidamide has obvious curative effect advantages, better safety, compliance, significantly prolonged survival of patients, significantly improved quality of life and cost advantages. It is an available and affordable innovative drug treatment for patients in China which has been widely used in clinical treatment. Nearly 1800 patients have benefited from the treatment of Chidamide (elpraza?) during the two-year marketing period.

 New breakthroughs: support innovative results to serve patients as soon as possible

The introduction of the national medical insurance directory negotiation mechanism is " a new leap forward in the development history of national medical policies". Linking the innovative medicines listed in recent years with the national medical insurance catalog, which firstly has greatly reduced the burden on medical expenses of patients in our country and improved the sense of access of the vast number of insured persons. Secondly, the successful incorporation into the national health insurance of major national new drug discovery special drugs, including Chidamide, fully reflects the state's emphasis on and support for medical innovation. At the same time, it also makes the speed at which China's innovative medicines enter the medical insurance catalog gradually connect with developed countries, which will greatly promote the innovative development of China's medical industry and enable the industrial innovation results to benefit more patients and the public as soon as possible!

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